Pelvic floor repair system

ABSTRACT

Systems, method, and devices related to surgically implantable supportive slings are presented herein. More specifically, in various embodiments, the systems, devices and methods relate to a surgically implantable supportive sling adapted to anchor in patient tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 13/964,685, filed on Aug. 12, 2013, entitled“PELVIC FLOOR REPAIR SYSTEM”, which, in turn, is a continuation of, andclaims priority to, U.S. patent application Ser. No. 12/983,589, filedon Jan. 3, 2011, entitled “PELVIC FLOOR REPAIR SYSTEM,” now U.S. Pat.No. 8,535,216, which, in turn, is a continuation of, and claims priorityto, U.S. patent application Ser. No. 11/493,148, filed on Jul. 25, 2006,entitled “PELVIC FLOOR REPAIR SYSTEM,” now U.S. Pat. No. 7,878,969,which, in turn, claims priority to U.S. Provisional Application No.60/702,539, filed on Jul. 25, 2005, and U.S. Provisional Application No.60/702,540, filed on Jul. 25, 2005, and U.S. Provisional Application No.60/715,362, filed on Sep. 8, 2005, all of which are incorporated byreference herein in their entirety.

BACKGROUND

Pelvic floor disorders afflict many women. According to some studies,about 1 out of 11 women need surgery for a pelvic floor disorder duringher lifetime. The pelvic floor generally includes muscles, ligaments,and tissues that collectively act to support anatomical structures ofthe pelvic region, including the uterus, the rectum, the bladder, andthe vagina. Pelvic floor disorders include vaginal prolapse, vaginalhernia, cystocele, rectocele, and enterocele. Such disorders arecharacterized in that the muscles, ligaments and/or tissues are damaged,stretched, or otherwise weakened, which causes the pelvic anatomicalstructures to fall or shift and protrude into each other or otheranatomical structures.

Moreover, pelvic floor disorders often cause or exacerbate femaleurinary incontinence (UI). One type of UI, called stress urinaryincontinence (SUI), affects primarily women and is generally caused bytwo conditions-intrinsic sphincter deficiency (ISD) and hypermobility.These conditions may occur independently or in combination. In ISD, theurinary sphincter valve, located within the urethra, fails to close (or“coapt”) properly, causing urine to leak out of the urethra duringstressful activity. In hypermobility, the pelvic floor is distended,weakened, or damaged, resulting in increases in intra-abdominal pressure(e.g., due to sneezing, coughing, straining, etc.) and consequently thebladder neck and proximal urethra rotate and descend. As a result, theurethra does not close with sufficient response time, and urine leaksthrough the urethra.

UI and pelvic floor disorders, which are usually accompanied bysignificant pain and discomfort, are typically treated by implanting asupportive sling in or near the pelvic floor region to support thefallen or shifted anatomical structures or to, more generally,strengthen the pelvic region by, for example, promoting tissue ingrowth.Often, treatments of stress incontinence are made without treating thepelvic floor disorders at all, potentially leading to an earlyrecurrence of the pelvic floor disorder.

Existing devices, methods, and kits for treatment typically applydelivery devices to position a supportive sling into a desired positionin the pelvic region by pushing or pulling the sling through thesurrounding tissue. When treating pelvic floor disorders and UI it isoften desirable to use a tanged mesh implant material, or to use animplant with anchoring projections along an edge of the material. Thetangs and projections may irritate the tissue if rubbed against itduring implantation. Furthermore, the tangs of the implant may make itdifficult to adjust the positioning or tension of the implant duringdelivery. If the implant is protected by a sleeve during delivery, extrasteps are needed to separate the sleeve from the implant and remove itfrom the body. Accordingly, medical operators and patients need improvedsystems, methods, and surgical kits for the treatment of pelvic floordisorders and/or urinary incontinence with minimal irritation of thepatient's tissue.

SUMMARY OF THE INVENTION

The invention addresses the deficiencies of the prior art by providingan improved implant delivery system. More particularly, in variousaspects, the invention provides an implant with an attachment strap anda sheath for use in delivering the implant to patient tissue.

In one aspect, the invention provides a system for delivering an implantto a patient for the treatment of pelvic floor disorders such ascystocele, rectocele, vaginal prolapse, and other similar disorders. Anexemplary system includes an implant having an attachment strap, an endtermination member attached to the strap, and one or more soft tissueanchors attached to the implant. The system also includes a shaft havinga slot located at a distal end for associating with the end terminationmember of the implant, and a sheath having a hollow center adapted toallow the shaft to extend therethrough.

According to one implementation, the slot in the shaft is L-shaped. Invarious configurations, the exemplary system further includes a handlecoupled to the shaft. The system may also include a handle coupled tothe sheath. According to one feature, the handle is removable.

According to various implementations, the one or more soft tissueanchors includes one or more tangs on the implant strap. In otherimplementations, the end termination member may be one or more of thesoft tissue anchor(s). The end termination member may be a loop or aring. The end termination member may have at least one radiallyextending leg, and may have two radially extending legs.

In various configurations, at least one of the shaft and the sheath issubstantially straight, or at least one of the shaft and the sheath hasa curved shape. According to one embodiment, the shaft is rigid and thesheath is flexible. According to another embodiment, the sheath is rigidand the shaft is flexible. In one implementation, the sheath is curvedand the shaft is flexible material, and the shaft bends to extendthrough the center of the sheath upon insertion.

According to one configuration, the shaft is longer than the sheath.According to another configuration, a tip is attached to a distal end ofthe sheath.

According to one implementation, the implant has two arms and aposterior extension portion and is adapted to be positioned under aposterior pelvic region. The two arms may arch in a posterior direction,toward the posterior pelvic region.

According to another implementation, the implant has four arms and isadapted to be positioned under an anterior pelvic region. The arms mayextend laterally from the center of the implant and in an anteriordirection, toward the anterior pelvic region.

According to a further implementation, the implant has six arms and isadapted to be positioned under the pelvic region. Two of the arms mayarch in a posterior direction, toward the posterior pelvic region, andfour of the arms may extend laterally from the center of the implant andin an anterior direction, toward the anterior pelvic region.

In various implementations, the implant has a tanged first edge. Theimplant may include a pattern of projections.

According to one aspect, the invention also provides a method fordelivering an implant to a patient including inserting a sheath having ahollow center into an incision in the patient, inserting a shaft of adelivery device into the center of the sheath, associating an endtermination member of the implant with the slot, advancing the shaft andthe associated implant through the sheath, and anchoring the implant inthe patient's pelvic floor region.

In one implementation, the shaft pulls the end termination memberthrough the sheath. In another implementation, the shaft pushes the endtermination member through the sheath. The shaft may be advanced intothe sheath prior to advancing the sheath into the incision. According toone feature, the end termination member is removed from the implantafter it has been advanced through the sheath

According to one implementation, the shaft is advanced into the sheathprior to advancing the sheath into the incision. Following insertion ofthe sheath in the patient, the shaft may be removed from the sheath,pulling the end termination member through the sheath. An arm of theimplant may also be pulled through the sheath. The sheath may be removedfrom the patient, leaving the implant anchored in patient tissue. In oneembodiment, the implant is anchored in patient tissue through one ormore tangs on the implant. In another embodiment, the end terminationmember anchors in patient tissue.

According to another implementation, the sheath is inserted through thepatient's gluteus maximus. The sheath may also be inserted through thesacrospinous ligament.

Other aspects and advantages of the invention are described below withrespect to various illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Various illustrative embodiments of the invention are described belowwith reference to the appended drawings, which may not be drawn to scaleand in which like parts are designated by like reference designations.These depicted embodiments are to be understood as illustrative of theinvention and not as limiting in any way.

FIG. 1 shows a sling assembly including an implant end terminationmember comprising a ring and two legs, attached to the arm of a meshimplant.

FIG. 2 shows an implant assembly including an end termination membercomprising a ring, attached to the arm of a mesh implant.

FIG. 3 shows an implant assembly including an end termination membercomprising a tab with an aperture, attached to the arm of a meshimplant.

FIG. 4 is a longitudinal cross sectional view of an end terminationmember comprising an association loop and a dilator, attached to the armof a mesh implant.

FIG. 5A shows an implant assembly including an end termination membercomprising a ring and a dilator, attached to the arm of a mesh implant.

FIG. 5B shows an implant assembly including an end termination membercomprising an elastic ring and a dilator, attached to the arm of a meshimplant.

FIG. 6 shows an implant assembly including an end termination memberincluding a cylindrical ring and two legs, attached to the arm of a meshimplant.

FIG. 7 shows a soft tissue anchor 700.

FIG. 8 shows a mesh implant including two arms and a tail, and adaptedto be positioned under a posterior pelvic region.

FIG. 9 shows a mesh implant including four arms and a tail, and adaptedto be positioned under an anterior pelvic region.

FIG. 10 shows a mesh implant including six arms and a tail, and adaptedto be positioned under the pelvic region.

FIG. 11 shows a mesh implant including six arms having end terminationmembers.

FIG. 12 shows a mesh implant having two tanged end portions and anontanged center portion.

FIG. 13 shows an implant having a center portion and two end portionswith a pattern of projections on their lateral edges.

FIG. 14 is a side-view of a straight sheath for use in delivering animplant to patient tissue.

FIG. 15 is a side-view of a sheath with a curved distal end, for use indelivering an implant to patient tissue.

FIG. 16 is a side-view of a curved sheath for use in delivering animplant to patient tissue.

FIG. 17 A is a side-view of a sheath with a spiral-shaped distal end foruse in delivering an implant to patient tissue.

FIG. 17B is a top-view of the sheath of FIG. 17 A.

FIG. 18A is a side-view of an alternative sheath with a spiral-shapeddistal end for use in delivering an implant to patient tissue.

FIG. 18B is a top-view of the sheath of FIG. 18A.

FIG. 19A is a side-view of a delivery device comprising a handle and astraight shaft, with an L-slot on the distal end of the shaft.

FIG. 19B shows an enlarged view of the L-slot on the distal end of thedelivery device shown in FIG. 19A.

FIG. 20A is a side-view of a delivery device comprising a handle and ashaft with a curved distal end, and a reduced-diameter tip portion atthe distal end.

FIG. 20B shows an enlarged view of the reduced-diameter tip-portion ofthe delivery device shown in FIG. 20A.

FIG. 21 is a side-view of a delivery device comprising a handle and acurved shaft, with an L-slot at the distal end of the shaft.

FIG. 22 shows an exemplary transobturator procedure for placement of animplant in patient tissue.

FIG. 23 shows another exemplary transobturator procedure for placementof an implant in patient tissue.

FIG. 24 shows an exemplary pelvic floor implant positioned in patienttissue.

DETAILED DESCRIPTION

As described in summary above, the invention, in one illustrativeembodiment, relates to systems and methods for delivering and placing amedical implant at an anatomical site in the body of a mammal. Inparticular, in various illustrative examples, the invention providesdelivery devices, systems, and methods for placing an implant, e.g., apelvic floor support mesh. In one aspect, the implant includes asupportive pelvic floor mesh having end termination members, which actas soft tissue anchors, for use in sling delivery. The implant isdelivered to the pelvic floor region, which may include the periurethraland other retropubic tissue. Delivery approaches may include atransobturator approach (inside-out or outside-in), a suprapubicapproach, a pre-pubic approach, a retropubic approach, a transabdominalapproach, and any combination of approaches. In one embodiment, thesystem includes a sheath having a hollow center and a delivery devicehaving a shaft. The shaft may be inserted through the sheath, attachedto an end termination member, and used to advance the end terminationmember and the associated implant through the sheath. The patient may beeither a female patient or a male patient.

More particularly, FIG. 1 shows a sling assembly 100 including anexemplary implant end termination member 104 attached to the arm of amesh implant 110. The end termination member 104 includes a ring 102, afirst arm 106, and a second arm 108. The arms 106 and 108 extendradially from the ring 102. In one embodiment, the end terminationmember 104 is a soft tissue anchor. The ring 102 may be sized and shapedto engage with a delivery device, such as, without limitation, thedistal end of a shaft or needle of the delivery devices 950, 970, and1000 described below with respect to FIGS. 19A-19B, 20A-20B, and 21.

According to one embodiment, in operation, an operator couples the ring102 to a slot in the shaft of a delivery device, such as the L-slot 960of FIG. 19B, for implantation into a patient, as will be discussed infurther detail below with respect to FIGS. 19A and 19B. According toanother embodiment, in operation, an operator places the ring 102 overthe tip of a delivery device shaft and slides the ring 102 down the tipuntil the ring 102 abuts against a step, shoulder, or other stoppingmechanism, as will be discussed in further detail below with respect toFIGS. 20A and 20B. The ring 102 includes an inner surface 102 a that, incertain embodiments, is tapered to inter-fit with the tip of a deliverydevice.

According to one embodiment, the ring 102 and arms 106 and 108 of theend termination member 104 are coplanar with the implant 110. As aresult, the implant assembly 100 has a low delivery profile. Thedelivery profile refers to the maximum cross-sectional area of apassageway through the patient's anatomy that is required for placementof the implant, and smaller delivery profiles may be beneficial at leastin part because they may reduce tissue damage during implant delivery.According to another embodiment, the end termination member 104 isflexible, such that the ring 102 and arms 106 and 108 may be arranged ina non-coplanar position.

The ring 102 may be any shape, including square, triangular, oval, orother preferred shapes. The ring 102 may also be any size, and inparticular may be configured to couple with shafts or needles of varyingdimensions.

The arms 106 and 108 may be sized and shaped to engage with and attachto the implant 110. The arms 106 and 108 of the end termination member104 extend radially from the ring 102 and adjoin at an angle 112,forming a V-shape. In certain embodiments, the end termination member104 is flexible such that the angle 112 can be increased or decreasedupon application of appropriate mechanical pressure. Similarly, theangle 120 formed between the arms 106 and 108 may also vary. Forexample, the arm 106 and 108 may be squeezed together, reducing theangle 120 to about zero degrees. By way of example, if the implantassembly 100 passes through tissue or through a sheath in a forwarddirection 114, the arms 106 and 108 interact with the tissue or with thesides of the sheath to increase the angle 112 and decrease the angle120, as the arms 106 and 108 are pushed together. If the implantassembly 100 passes through tissue in a retrograde direction 118, thearms 106 and 108 may interact with the tissue to decrease the angle 112and increase the angle 120, as the arms 106 and 108 are pushed apart.The varying angles 112 and 120 facilitate movement of the implantassembly 100 in the forward direction 114 and impedes movement of themesh strap 110 in the retrograde direction 118. In certain embodiments,the angle 112 may vary from between about 0 degrees to about 90 degrees,and in other embodiments, the angle 112 may vary to more than about 90degrees. Similarly, in various embodiments, the angle 120 may vary frombetween about 0 degrees to about 110 degrees, and in other embodiments,the angle 120 may vary to more than about 110 degrees. In oneembodiment, the flexibility of the end termination member 104 may vary.The flexibility of the end termination 104 and the measurement of theangles 112 and 120 are generally chosen to suit the particular deliverypath and location for anchoring the implant, as well as the conditionbeing treated.

According to an additional embodiment, the V-shaped configuration of thearms 106 and 108 acts to engage with patient tissue to resist removalonce the implant assembly 100 is implanted. The depicted arms 106 and108 extend beyond the width 110 a of the mesh implant 110 to provideadditional engagement with tissue, but in other illustrativeembodiments, the arms 106 and 108 may have any length, and may notextend beyond the width 110 a of the implant 110. In one embodiment, thedistance between the arms 106 and 108 is less than the width of theimplant 110, such that the arms 106 and 108 do not extend to the edge ofthe implant 110.

According to one embodiment, the end termination member 104 may bemolded to the implant 110, as described in further detail in U.S. patentapplication “Systems, Devices, and Methods for Treating Pelvic FloorDisorders,” Ser. No. 11/400,111, filed Apr. 6, 2006, which isincorporated herein by reference in its entirety. According to a furtherembodiment, also described in the reference “Systems, Devices, andMethods for Treating Pelvic Floor Disorders,” the end termination member104 may include two pieces: a top piece, and a bottom piece. Accordingto this embodiment, the two pieces may be snapped together to attach theend termination member 104 to the implant 110.

FIG. 2 shows an implant assembly 200 including an end termination member204 and a mesh implant 210. The end termination member 204 includes aring 202, and does not include radially extending legs. A manufacturermay affix the end termination member 204 to the implant 210 using any ofthe methods described above. In the depicted implant assembly 200, themanufacturer has trimmed corners of the implant 210 at locations 210 aand 210 b. According to alternative embodiments, the corners of theimplant may not be trimmed, or the corners may be trimmed to anysuitable shape, including round, triangular, and square.

FIG. 3 shows another embodiment of an implant assembly 300 including endtermination member 304 and mesh implant 310. The end termination member304 lies substantially coplanar with the implant 310, and includes atab-shaped region 308 and an aperture 302. The aperture 302 may be sizedand shaped to couple with the shaft of a delivery device. In oneembodiment, the aperture 302 is sized, shaped and positioned in the tabregion 308 to couple with the slot in the end of the shaft of a deliverydevice, such as the L-slot 960 shown in FIG. 19B. In one embodiment, theaperture 302 is small (i.e., it has a diameter of less than about 2 mm),and is sized to couple with the narrow needle of a delivery device. Inother embodiments, the aperture 302 is sized to allow an operator tothread a filament therethrough. The filament may couple to a separatesoft tissue anchor as described in connection with other embodimentsherein. In an exemplary manufacturing technique, a manufacturer dips theimplant 466 in a curable plastic to form the end termination member 304.The manufacturer then trims the plastic to create the tab shape andpunches a hole through the plastic to create the aperture 302. However,in alternative embodiments, the manufacturer may pre-form the endtermination member 304 and subsequently snap-fit, glue, stitch, orotherwise attach it to the implant 310. Additional embodiments of theend termination member 304 are described in the above reference“Systems, Devices, and Methods for Treating Pelvic Floor Disorders.”

FIG. 4 is a longitudinal cross sectional view of a sling assembly 400including and end termination member 404 and an implant 410. The endtermination member 404 includes an association loop 402 and a dilator406. According to a preferred embodiment, the dilator 406 is a rigidpolymer tube of approximately 2 cm in length terminating in a conicaltip. Embedded and secured along the length of the dilator 406 are twoends of a wire 408, which may be formed from twisted metal strands. Thewire 408 extends from the conical tip of the dilator 406 to form anassociation loop 402. According to one embodiment, the association loop402 extends approximately 15 mm from the end of the conical tip of thedilator 406. According to other embodiments, the association loopextends any suitable distance from the conical tip of the dilator 406,including about 5 mm, about 10 mm, about 20 mm, about 25 mm, about 30mm, about 35 mm, about 40 mm, about 50 mm, about 75 mm, about 1 cm, andmore than 1 cm. The association loop 402 is preferably deformable, butgenerally shape-retaining Thus, according to one embodiment, the shapeof the association loop 402 may be changed by outside pressure, but theassociation loop 402 will return to its original shape upon release ofthe outside pressure.

According to one embodiment, the association loop 402 of the endtermination member 404 is sized and shaped for coupling to a slot in theend of a shaft of a delivery device, such as the L-slot 960 of deliverydevice 950 shown in FIGS. 19A and 19B.

FIG. 5A shows an implant assembly 500, including an end terminationmember 504 and a mesh implant 510. The end termination member 504includes a ring 502 and a dilator 508. The dilator 508 may also act as asoft tissue anchor. According to one embodiment, the ring 502 threadsthrough apertures 514 and 516 in a first shoulder region 512 of thedilator 508. More particularly, the ring 502 couples with dilator 508 bythreading through apertures 514 and 516, and couples with the meshimplant 510 by threading through apertures 518 and 520 in the meshimplant 510. According to one embodiment, the ring 502 is constructed ofa rigid or semi-rigid material, and maintains its shape. In anotherembodiment, the ring 502 is constructed of a deformable material that isshape retaining.

In an alternative embodiment, as shown in FIG. 5B, the ring 502 isflexible, and may be constructed from an elastic material. In thisembodiment, the ring 502 stretches to absorb lateral stresses. Wovensurgical implants may stretch and damage due to stresses during deliveryof the implant, and stretching of the ring 502 may help preventstretching and damage to the implant 510 during delivery. Additionally,elastic rings adjust to short term and/or long term changes in thepatient's changing anatomy to prevent damage to the surgical implant510. For example, when the patient sneezes, coughs, or jumps, muscles inthe pelvic region can contract and anatomical structures may shift.Anatomical structures may also shift over long periods of time becauseof the patient's changing anatomy due to, for example, weight gain orweight loss. In such cases, elastic rings stretch to absorb the stressescaused by these short-term and long-term changes, thereby preventing thechanges from damaging the surgical implant 510.

According to various embodiments, the ring 502 is sized and shaped tocouple with the shaft of a delivery device. In one embodiment, the ring502 couples with a slot in the end of the shaft of a delivery device,such as the L-slot 960 of delivery device 950 shown in FIGS. 19A and19B.

FIG. 6 shows an implant assembly 600 including an end termination member604 and a mesh strap 610. The end termination member 604 includes arms606 and 608 and a ring 602 that has a circular cross-section lying in aplane that is perpendicular to a plane of the mesh strap. According tovarious embodiments, the end termination member 604 couples to the endof the shaft of a delivery device, such as the delivery device 970described below with respect to FIGS. 20A and 20B. The orientation ofthe ring 602 with respect to the end termination member 604, as comparedwith the ring 102 with respect to the end termination member 104 of FIG.1, results in a different orientation of the mesh implant 610 withrespect to the delivery device when the mesh implant and the device arecoupled. This alternative orientation results in the implant 610aligning with the tip of the shaft, as opposed to extending from theshaft tip at about a 90 degree angle. The alternative orientation usingend termination member 604 may be preferred by a medical operator whenthe operator is delivering the mesh implant 610 through a narrowanatomical incision, through a narrow pathway in a patient's anatomy,and/or through a sheath.

Other exemplary alternatives to the end termination members 104, 204,304, 404, 504, and 604 are disclosed in U.S. patent application Ser. No.10/542,365 and U.S. patent application Ser. No. 11/152,898, the contentsof which are incorporated by reference herein in their entirety.

FIG. 7 shows a soft tissue anchor 700, which may be attached to the armof an implant, such as implants 730, 750, and 780 shown in FIGS. 8, 9,and 10, and described below. The soft tissue anchor 700 includes acenter portion 702, and tabbed projections 704, 706, 708, 710, 712, and714. Additional projections may be present on the reverse side (notshown) of the anchor 700. The center portion 702 of the anchor 700 maybe solid or hollow. In one embodiment, the center portion 702 includes athrough-aperture 718. The soft tissue anchor 702 may be adapted tointerfit with the shaft of a delivery device, such as the shaft 972 ofthe delivery device 970, shown in FIGS. 20A and 20B, and discussedbelow.

FIG. 8 shows a mesh implant 730 including two arms 732 and 734, and aposterior extension portion 738. According to one embodiment, theimplant 730 is adapted to be positioned under a posterior pelvic region,and may provide posterior pelvic floor support. According to theillustrative embodiment, the two arms arch in a posterior direction,toward the posterior pelvic region. The mesh implant 730 may alsoinclude an anteriorly extending portion 740. According to oneembodiment, any of the end termination members 104, 204, 304, 404, 504,and 604 may be attached to the arms 732 and 734 of the implant 730.According to a further embodiment, any of the end termination members104, 204, 304, 404, 504 and 604 may be attached to the posteriorextension portion 738. According to another embodiment, a combination ofvarious end termination members may be used. In yet another embodiment,the arms 732 and 734 may be tanged, similar to the arms 840 a and 840 bof FIG. 12.

FIG. 9 shows a mesh implant 750 including four arms 752, 754, 756, and758 and a posterior extension portion 760. According to one embodiment,the implant 750 is adapted to be positioned under an anterior pelvicregion, and may provide anterior pelvic floor support. According toanother embodiment, the arms 752, 754, 756, and 758 extend laterallyfrom the center 762 of the implant 750 and in an anterior direction,toward the anterior pelvic region. According to one embodiment, any ofthe end termination members 104, 204, 304, 404, 504, and 604 may beattached to the arms 752, 754, 756, and 758 of the implant 750.According to a further embodiment, a combination of various endtermination members may be used. In yet another embodiment, the arms752, 754, 756, and 758 may be tanged, similar to the arms 840 a and 840b of FIG. 12.

FIG. 10 shows a mesh implant 780 including six arms 782, 784, 786, 788,790, and 792 and a tail 794. According to one embodiment, the implant780 is adapted to be positioned under the pelvic region, and may providepelvic floor support. According to another embodiment, two arms 782 and784 of the implant 780 arch in a posterior direction, toward theposterior pelvic region, while four arms 786, 788, 790, and 792 extendlaterally from the center 798 of the implant and in an anteriordirection, toward the anterior pelvic region. According to oneembodiment, any of the end termination members 104, 204, 304, 404, 504,and 604 may be attached to the arms 782, 784, 786, 788, 790, and 792 ofthe implant 780. According to a further embodiment, a combination of thevarious end termination members may be used. In yet another embodiment,the arms 782, 784, 786, 788, 790, and 792 may be tanged, similar to thearms 840 a and 840 b of FIG. 12.

FIG. 11 shows a mesh implant 800 including six arms 802, 804, 806, 808,810, and 812, having end termination members 822, 824, 826, 828, 830,and 832, respectively. While the end termination members 822, 824, 826,828, 830, and 832 are depicted as being similar to the end terminationmember 104 of FIG. 1, the end termination members 822, 824, 826, 828,830, and 832 may include any of the end termination members 104, 204,304, 404, 504, and 604, or any combination of end termination members104, 204, 304, 404, 504, and 604.

FIG. 12 shows an exemplary mesh implant 840 having two end portions 840a and 840 b and a center portion 840 c. As shown in FIG. 12, the endportions 840 a and 840 b have tanged edges, which help to anchor themesh implant following implantation. The center portion 840 c has smoothnon-tanged edges, which may help prevent irritation of the supportedtissue or organ.

FIG. 13 shows an exemplary implant 850 having two end portions 850 a and850 b and a center portion 850 c. As shown in the figure, the endportions 850 a and 850 b comprise a pattern of projections along theirlateral edges, which help to anchor the implant in patient tissue uponimplantation. The center portion 850 c had smooth edges with noprojections, which may help prevent irritation of the supported tissueor organ.

According to various embodiments, the arms of an implant are theattachment straps of the implant. According to another embodiment, theattachment straps form a continuum with the center portion of theimplant, and may include one or more nontanged portions.

In one aspect, the implants are inserted into a patient by the use of asheath. FIGS. 14-16, 17 A and 18A are side-views of various exemplarysheathes for such use. According to one embodiment, the sheathes arehollow, to allow for passage of a shaft therethrough. FIG. 14 depicts asheath 860 having a proximal end 860 a, a distal end 860 b, and astraight portion 864 extending from the proximal end 860 a to the distalend 860 b of the sheath 860. FIG. 15 depicts a sheath 870 having aproximal end 870 a and a distal end 870 b. The sheath 870 includes astraight portion 874 extending from the proximal end 870 a of the sheath870, and a curved portion 876 extending from the straight portion 874 tothe distal end 870 b of the sheath 870. FIG. 16 depicts a side view of asheath 880 having a proximal end 880 a and a distal end 880 b. Thesheath 880 includes a straight portion 884 extending from the proximalend of the sheath 880, an upward-curving portion 886, extending from thedistal end of the straight portion 884, and a downward-curving portion888, extending from the distal end of the upward-curving portion 886 tothe distal end 880 b of the sheath 880. According to one embodiment, thesheathes shown in FIGS. 14-16 all lie substantially in one plane.

FIG. 17 A depicts a side view of a sheath 900 for use in delivering animplant to patient tissue, while FIG. 17B depicts a top view of thesheath 900. The sheath 900 has a proximal end 900 a and a distal end 900b. The sheath 900 includes a first straight portion 904, a secondstraight portion 906, a curved portion 908, and a third straight portion910. Optionally, the sheath 900 further includes a removable tip 912.The first straight portion 904 extends distally away from the proximalend 900 a of the sheath 900 along a longitudinal axis 916. The secondstraight portion 906 extends distally from, but at an angle to the firststraight portion 904. In the illustrative embodiment, the secondstraight portion 906 is substantially coplanar in a first plane with thefirst straight portion 904. The first curved portion 908 of the sheath900 extends from a distal end of the second straight portion 906 andcurves the sheath 900 back toward the axis 916. The third straightportion 910 of the sheath 900 extends from a distal end of the firstcurved portion 908, as shown in FIG. 17B. The first curved portion 908and the third straight portion 910 are substantially coplanar with eachother in a second plane. As depicted in FIG. 17B, the curved section 908defines a substantially constant radius curve.

The optional conical tip 912 of the sheath 900 may attach to the distalend 900 b of the sheath 900. The conical tip 912 may be configured forpercutaneous punctuation and/or advancement through tissue. However, thetip 912 may be blunt or sharp. A blunt tip provides some resistance tounintended penetration through tissue or organ, such as the bladder.

FIG. 18A depicts a side-view of a sheath 930 configured as a variationof the illustrative sheath 900 of FIG. 17 A. FIG. 18B depicts a top-viewof the sheath 930. The sheath 930 has a proximal end 930 a and a distalend 930 b. Similar to sheath 900, sheath 930 includes a straight portion934 extending distally away from the proximal end 930 a of the sheath930 along a longitudinal axis 946, and a second straight portion 936extending distally from, but at an angle to the first straight portion934, and substantially coplanar in a first plane with the first straightportion 934. The sheath 930 further includes a first curved portion 938extending from a distal end of the second straight portion 936 andcurving the sheath 930 back toward the axis 946. A third straightportion 940 of the sheath 930 extends from a distal end of the firstcurved portion 938, as shown in FIG. 18B. The sheath portions 934, 936,and 938 are arranged such that the angle between the plane of the first934 and second 936 straight portions and the plane of the curved portion938 are substantially orthogonal to each other. Variations on theorientation of the (1) first plane and the second plane, (2) the anglebetween the sheath straight portions, and/or (3) the angle between thecurved sheath portion and the adjacent sheath straight portions, otherthan is shown here with respect to the sheathes in FIGS. 17 A-17B, and18A-18B, are contemplated as desired to optimize the movement that isused during a particular procedure. According to some embodiments, thesheath 930 may also include a removable tip, such as tip the 912, at thedistal end 930 b.

According to one embodiment, a handle may be associated with any of thesheathes of FIGS. 14-16, 17 A-17B, and 18A-18B during insertion, and thehandle may extend over a portion of or the entirety of the firststraight portion. For the sheathes shown in FIGS. 16, 17 A-17B, and18A-18B, preferably the distal straight portion and the curved portionsare the only parts of the sheath that penetrate into a patient's body.

According to one embodiment, a hub containing medication may be insertedinto the proximal end of any of the sheathes of FIGS. 14-16, 17A-17B,and 18A-18B. The sheathes 860, 870, 880, 900, and 930 may be formed froma metal or a polymeric material. Examples of suitable metals include,but are not limited to, stainless steel, titanium, and alloys such asnitinol. Suitable polymers, which can be used as a coating on a metal toform the sheath, include but are not limited to, plastics such aspolytetrafluoroethylene (PTFE). In some configurations, the sheath isrigid. However, in other configurations, the sheath is flexible.

In one illustrative embodiment, the surface of the sheath is smooth andmay be coated with one or more drugs such as anesthetic,anti-inflammatory, coagulating, anticoagulating, antibiotic, orantimicrobial agents. The drug may be delivered to the patient's tissuewhile the sheath is in contact with the tissue. The surface of thesheath may be coated with a light-absorbing coating to reduce glare, forexample, under a cystoscope. The coating may be a polymer, such asTeflon, or other suitable material, and may be colored to aid indetection. The surface of the sheath may be painted so that one caneasily tell it apart from surrounding tissue and fluid under acystoscope to make it easier to detect under the cystoscope.

The sheath may be at least partly hollow, and it may include a lumen(not shown) that has one or more openings on the sheath, for example, atthe distal tip or along the side of the shaft. The cross-section of thesheath may have a constant shape and size, or its shape and/or size mayvary along its length. The cross-section of the sheath may assume anysuitable shape, for example, circular, semi-circular, oval, triangular,or rectangular. In other embodiments, the distal end may include anenlarged, flared portion to dilate tissue beyond the nominal diameter ofthe sheath.

Other exemplary sheathes are disclosed in U.S. Pat. No. 6,638,210,entitled “Surgical Apparatus and Methods for Delivery of a Sling in theTreatment of Female Urinary Incontinence,” the contents of which areincorporated by reference herein in their entirety.

FIGS. 19A-19B, 20A-20B, and 21 are side-views of various deliverydevices for use in delivering an implant to patient tissue. FIG. 19Ashows a delivery device 950 having a straight shaft 952 and a handle954. According to one embodiment, the handle 954 is optional, and theshaft 952 may be used without the handle 954. The handle has a proximalend 954 a and a distal end 954 b, and the shaft 952 has a proximal end952 a and a distal end 952 b. The proximal end 952 a of the shaft 952extends from the distal end 954 b of the handle 954. The distal end 952b of the shaft 952 includes an L-slot 960, as shown enlarged in FIG.19B.

FIG. 19B is a side view of an L-slot 960 on a distal end 952 b of ashaft 952 of a delivery device 950. The L-slot 960 is preferably formedfrom a first channel 960 a approximately 2 mm in length and 1 mm inwidth extending radially into the shaft 952 and a second channel 960 bapproximately 5 mm in length and 1 mm in width extending distally alongthe length of the distal end 952 b of the shaft 952 from an innerterminal end of the first channel 960 a. In certain illustrativeembodiments, an end termination member slides radially into the firstchannel 960 a and along the second channel 960 b to hook one end of animplant onto the distal end 952 b of the shaft 952 of a delivery device950.

An advantage of the L-slot 960 configuration is that the delivery device950 may be used to pull an implant into place. During withdrawal of thedelivery device 950, the distally extending orientation of the secondchannel 960 b causes an associated end termination, such as endtermination member 104, to slide to the distal most position in theL-slot 960. This tends to maintain the association between the endtermination, and thus the implant, and the shaft 952, keeping the endtermination member hooked into the second channel 960 b duringwithdrawal of the delivery device. Additionally, the end terminationmember remains free to slide along the second channels 960 b. When slidto a proximal-most position in the second channel 960 b, the endtermination member may be slid radially out of the first channel 960 ato unhook the implant from the delivery device(s) with minimal effort.

According to one embodiment, the shaft 952 is inserted into a sheath,such as the sheath 860 of FIG. 14, and an end termination member of animplant is attached to the L-slot 960, allowing a user to drag the endtermination member and the associated arm of an implant into the sheathby pulling the shaft 952 back out of the sheath. According to thisembodiment, if the sheath is positioned in patient tissue and the endtermination member of an implant is pulled through the sheath,dissociation of the implant from the delivery device and removal of thesheath will result in positioning of the arm of the implant in thelocation previously occupied by the sheath.

This process may be repeated with another end termination member onanother arm of the implant, such as implant 780 shown in FIG. 10, usingthe same or a second delivery device.

In some alternative configurations, the second channel 960 b of anL-slot 960 extends proximally, rather than distally, along the distalend of a shaft of any delivery device of the invention, and the shaft isused to push implant through the sheath. When pushing or inserting theshaft of the delivery device into the sheath, the proximally extendingorientation of the second channel causes the end termination, forexample the end termination member 104 as depicted in FIG. 1, to slideto a proximal most position in the L-slot. This tends to maintain theend termination, and thus the sling assembly comprising the endtermination, hooked onto the second channel during insertion of theshaft of the delivery device into the sheath.

An alternative delivery device 970 for pushing an implant through asheath is shown in FIG. 20A. The delivery device 970 having a shaft 972and a handle 974. According to one embodiment, the handle 974 isoptional, and the shaft 972 may be used without the handle 974. Thehandle has a proximal end 974 a and a distal end 974 b, and the shaft972 has a proximal end 972 a and a distal end 972 b. The shaft 972includes a straight portion 978, extending from the distal end 974 b ofthe handle 974, and a curved portion 980 extending from the distal endof the straight portion 978 to the distal end of the shaft 972 b. Thedistal end 972 b of the shaft 972 includes a reduced-diameter tipportion 984, as shown enlarged in FIG. 20B.

FIG. 20B shows an enlarged side view of the distal end 972 b of theshaft 972 of FIG. 20A. The distal end 972 b of the shaft 972, as shownin FIG. 20B, includes part of the curved portion 980, shoulder 988, anda reduced diameter tip-portion 984. According to one embodiment, theshaft 972 may couple with an end termination, such as end terminationmember 104 of FIG. 1 or end termination member 604 of FIG. 6, such thatthe ring of the end termination member slides down the tip-portion 984until the ring abuts the shoulder 988. According to one embodiment, theshoulder 988 prevents passage of the ring of an end termination memberpast the reduced-diameter tip 984.

According to one embodiment, the tip-portion 984 has a constantcross-section. In another embodiment, the cross-section of thetip-portion tapers toward the distal end. In this embodiment, thetip-portion may be formed to interfit with an end termination memberincluding a ring with a tapered inner surface.

FIG. 21 depicts a side view of a delivery device 1000 including a shaft1002 and a handle 1004. According to one embodiment, the handle 1004 isoptional, and the shaft 1002 may be used in operation without the handle1004. The handle 1004 has a proximal end 1004 a and a distal end 1004 b.The shaft 1002 extends from the distal end 1004 b of the handle 1004,and has a proximal end 1002 a and a distal end 1002 b. The shaft 1002includes a straight portion 1008 extending from the distal end of thehandle 1004 b, an upward-curving portion 1010, extending from the distalend of the straight portion 1008, and a downward-curving portion 1012,extending from the distal end of the upward-curving portion 1010 to thedistal end 1002 b of the shaft 1002. The distal end 1002 b of the shaftincludes an L-slot 1014, similar to the L-slot 960 shown enlarged inFIG. 19B.

According to various embodiments, the distal ends 952 b, 972 b, and 1002b of the shafts 952, 972, and 1002 of FIGS. 19A, 20A, and 21 may includeany type of tip, including the L-slot 960 and the reduced-diameter tip984 of FIGS. 19B and 20B, respectively. Furthermore, the shafts 952,972, and 1002 may be attached to any type of handle, including forexample, handles 954, 974, and 1004 of FIGS. 19A, 20A, and 21. In otherembodiments, the shafts 952, 972, and 1002 may be used during anoperative procedure without an associated handle. According to oneembodiment, the shafts 952, 972, and 1002 shown in FIGS. 19A, 20A, and21 all lie substantially in one plane.

According to one embodiment, in operation, the shafts 952, 972, and 1002are inserted into associated sheathes, and used to pull or push an endtermination member and associated implant arm through the sheath. Invarious embodiments, the sheathes and/or the shafts may be flexible, toallow a shaft, such as shafts 952, 972, and 1002 to pass through asheath, such as sheathes 860, 870, 880, 900, and 930. Further deliverydevices not shown herein, may include shafts shaped similarly to thesheathes 900 and 930 shown in FIGS. 17 A and 18A, respectively.

FIG. 22 shows aspects of an exemplary transobturator procedure 1050 forplacement of an implant 1052 in patient tissue. The exemplary implantincludes end termination members 1062 and 1066, similar to the endtermination member 104 FIG. 1. However, the end termination members 1062and 1066 may be any suitable end termination members, such as endtermination member 204 of FIG. 2, or end terminations 304, 404, 504, or604 described above. FIG. 23 shows a similar procedure 1080 forplacement of an implant 1082, similar to implant 780 of FIG. 10. Theexemplary implant 1082 includes end termination members 1084, 1086,1088, 1090, 1092, and 1094. In one embodiment, the implants 1052 and1082 may include tanged mesh attachment straps, similar to the implant840 of FIG. 12.

In the exemplary technique, the patient is placed on an operating tablein a position to provide access to the pelvic region. The operator maysubject the patient to local anesthesia, regional anesthesia, and/orgeneral anesthesia or sedation according to his preference. Next, theoperator makes a transverse incision (not shown) in the anterior vaginalwall of the patient and dissects the incision bilaterally according tohis preference using, for example, surgical scissors. In certainimplementations, the operator dissects bilaterally to the inferior pubicramus on both sides of the patient. The incision may be made in thevagina so as to allow the inserted shaft to be near, contact, applypressure to, or poke the skin at a position that is generally in linewith the urethral meatus.

Next, the operator makes a vertical skin incision in the groin, largeenough to insert the tip of the sheath just lateral to the edge of theinferior pubic ramus at the junction where the inferior pubic ramus andthe adductor longus muscle meet. This may be repeated on thecontralateral side. Thus, according to one implementation, for each sideof the patient tissue, there are two incisions: a vaginal wall incisionand a vertical skin incision.

Next, the operator accesses the patient's pelvic region via the twoincisions to insert the implant into the patient's pelvic region andsecure the implant within the region so that at least a portion of theimplant is located posterior to the bladder neck. According to theexemplary technique, to accomplish this, the operator inserts the sheath1054 through a vertical skin incision, piercing through the obturatormuscle and obturator membrane, toward the vaginal wall. The operator mayhear and/or feel a pop indicating that he has pierced the obturatormembrane. According one embodiment, for insertion, the distal end of thesheath 1054 may include a tip, such as tip 912 of FIG. 17B, and theproximal end of the sheath 1054 may be removably coupled to a handle,such as handles 954, 974, and 1004 of FIGS. 19,20, and 21.

Once the sheath 1054 has passed through the obturator foramen 1070, theoperator may turn the handle at a 45° angle medial toward the midline,and place the opposite hands forefinger into the lateral dissection ofthe vaginal incision, placing the fingertip on the distal end of thesheath 1054. In one implementation, the operator uses his fingertip toguide the distal end of the sheath around the inferior pubic ramus andthrough the vaginal incision, maintaining contact with the finger. Theoperator may palpate during delivery as preferred. The operator may alsouse the posterior portion of the patient's pubic bone as an anatomicallandmark to assist in guiding the needle. According to one feature,after the sheath 1054 is in place, the optional tip and handle may beremoved from the sheath 1054.

According to the exemplary technique, following sheath 1054 insertion, ashaft 1060 is inserted into the sheath 1054, such that the distal end ofthe shaft 1060, including the L-slot 1064, extends past the distal endof the sheath 1054. According to one embodiment, the shaft 1060 isflexible, easing insertion of the shaft 1060 into the sheath 1054.

According to an alternative embodiment, the shaft 1060 is inserted intothe sheath 1054 before the sheath 1054 is inserted into patient tissue,and the shaft-sheath combination is inserted into the patient in atransobturator method as described above, such that the distal end ofthe sheath 1054 exits the tissue through the vaginal incision. In thisembodiment, the sheath 1054 may be flexible and the shaft 1060 may berigid.

In another embodiment, the sheath is inserted via an inside-out method.According to this method, the sheath is inserted first through thevaginal incision, then through the obturator foramen and toward thevertical skin incision. The shaft may then be inserted into the sheathvia the outside-in method (toward the vaginal incision), as describedabove.

As shown in FIG. 22, the distal end of the shaft 1060 includes an L-slot1064, similar to the L-slot 960 shown in FIG. 19B. After the operatorinserts the sheath 1054 and the shaft 1060 into patient tissue, theL-slot 1064 extends beyond the distal end of the sheath 1054. Theoperator then hooks the end termination member 1062 of the implant 1052on to the L-slot 1064, to couple the implant 1052 to the shaft 1060. Theoperator removes the shaft 1060 from the sheath 1054, for example bypulling handle 1058, thereby advancing the arm 1068 of the implant 1052through the sheath 1054. According to one embodiment, the arms of theend termination member 1062 may be squeezed together to allow the endtermination member 1062 to fit into and advance through the sheath 1054.Once the arm 1068 of the implant 1052 has been pulled through the sheath1054, the end termination member 1062 of the implant 1052 is uncoupledfrom the shaft 1060, by sliding the ring of the end termination member1062 out of the L-slot 1064. In one example, the arm 1068 includesanchoring tangs or projections as shown in the implants 840 and 850 ofFIGS. 12 and 13, and the end termination member 1062 is removed (e.g.,cut off) from the arm 1068. The sheath 1054 may then be removed from thepatient, by pulling the proximal end of the sheath, leaving the arm 1068of the implant 1052 in place. In one embodiment, this allows forimplantation of a tanged mesh implant, such as implant 840 of FIG. 12,or an implant with lateral projections, such as implant 850 of FIG. 13,without unnecessary irritation of patient tissue such as may be causedby advancing a rough edge across patient tissue. The tangs orprojections may act as a soft tissue anchor to anchor the arm in patienttissue. The operator repeats this process for the other end terminationmember 1066, inserting it on the contra-lateral side of the patient.

FIG. 23 shows aspects of an exemplary transobturator procedure 1080 forplacement of an implant 1082 in patient tissue. The exemplary implant1082 is substantially the same as the implant 780 shown in FIG. 10. Theimplant 1082 includes arms 1104, 1106, 1108, 1110, 1112, and 1114, and aposterior extension portion 1116. Attached to the distal end of each arm1104, 1106, 1108, 1110, 1112, and 1114 of the implant 1082, is an endtermination member 1084, 1086, 1088, 1090, 1092, and 1094, respectively.The end termination members 1084, 1086, 1088, 1090, 1092, and 1094 maybe the same as the end termination member 204 of FIG. 2, or they may beany of the end terminations 104, 304, 404, 505, or 604 described above.According to one embodiment, an end termination member is also attachedto the distal end of the posterior extension portion 1116. In oneembodiment, the arms 1104, 1106, 1108, 1110, 1112, and 1114 are tanged,similar to the end portions 840 a and 840 b of the implant 840 of FIG.12.

The implant arms 1104, 1106, 1108, 1110, 1112, and 1114 may each bedelivered to a different location in the patient tissue using a varietyof delivery approaches. According to one implementation, the anteriorimplant arms 1108, 1110, 1112, and 1114 are implanted using atransobturator procedure, as described above with respect to FIG. 22.FIG. 23 shows the placement of the arm 1114.

According to one embodiment, the location of the puncture of theobturator membrane within the obturator foramen 1120 depends on theimplant arm 1104, 1106, 1108, 1110, 1112, or 1114 being delivered. Forexample, the operator delivers an anterior implant arm (e.g., implantarm 1114) through a sufficiently anterior region of the obturatorforamen 1120 so that the implant 1082 extends to and supports anteriorregions of the patient's pelvic floor, while the operator delivers asecond anterior implant arm (e.g., the implant arm 1110) through asufficiently posterior region of the obturator foramen 1120 so that theimplant extends to the posterior regions of the patient's pelvic floorand provides posterior support. The implant arms 1108, 1110, 1112 and1114 may be tanged or include projections, such as the implants 840 and850 of FIGS. 12 and 13, and may be delivered using substantially thesame method as described above with respect to the implant arm 1068 ofFIG. 22. Thus, following insertion of each of the anterior arms 1108,1110, 1112, and 1114 through the obturator foramen, the associated endtermination members 1094, 1092, 1090, and 1088 are removed, and thetangs or projections act as soft tissue anchors, anchoring the arms1108, 1110, 1112, and 1114 in patient tissue.

The posterior implant arm 1106 may be inserted using a different type ofprocedure that is not transobtural. In one implementation, the implantarm 1106 is inserted via a transgluteal procedure and secured throughthe sacrospinous ligament. To place the implant arm 1106, the operatormakes an incision in the posterior vaginal wall and an appropriatelateral dissection to expose the sacrospinous ligament. The operatorthen makes a gluteal incision in the skin of the buttocks lateral to andbelow the anus, large enough to insert the tip of the sheath. A sheathis inserted into the gluteal incision, and through the sacrospinousligament. In one embodiment, the sheath may extend through thesacrospinous ligament approximately 2 cm from the ischial spine. This isrepeated on the contralateral side. Thus, according to oneimplementation, for each side of the patient tissue, there is a glutealincision, and an exposure of the sacrospinous ligament by lateraldissection from the vaginal incision.

According to this implementation, the operator accesses the patient'spelvic region via the two incisions to insert the implant into thepatient's posterior pelvic region. To accomplish this, the operatorinserts the sheath through a gluteal incision, and through thesacrospinous ligament, toward the vaginal wall. According oneembodiment, for insertion, the distal end of the sheath may include atip, such as tip 912 of FIG. 17B, and the proximal end of the sheath maybe removably coupled to a handle, such as handles 954, 974, and 1004 ofFIGS. 19, 20, and 21. According to one feature, after the sheath is inplace, the optional tip and handle are removed from the sheath.

According to the exemplary technique, following sheath insertion, ashaft is inserted into the sheath, such that the distal end of theshaft, including the L-slot, extends past the distal end of the sheath.According to one embodiment, the shaft is flexible to ease insertion ofthe shaft into the sheath.

According to an alternative embodiment, the shaft is inserted into thesheath before the sheath is inserted into patient tissue, and theshaft-sheath combination is inserted into the patient in a transglutealmethod as described above, such that the distal end of the sheath exitsthe tissue through the vaginal incision. In this embodiment, the sheathmay be flexible and the shaft may be rigid. In another embodiment, thesheath is inserted via an inside-out method.

According to this method, the sheath is inserted through the vaginalincision and then through the sacrospinous ligament, toward the glutealincision.

In certain implementations, the distal end of the shaft includes anL-slot, similar to the L-slot 960 shown in FIG. 19B. After the operatorinserts the sheath and the shaft into patient tissue, the L-slot extendsbeyond the distal end of the sheath. The operator then hooks the endtermination member 1086 of the implant 1082 on to the L-slot, to couplethe implant 1082 to the shaft. The operator removes the shaft from thesheath, for example by pulling handle, thereby advancing the arm 1106 ofthe implant 1082 through the sheath. Once the arm 1106 of the implant1082 has been pulled through the sheath, the end termination member 1086of the implant 1082 is uncoupled from the shaft, by sliding the ring ofthe end termination member 1086 out of the L-slot. In one example, thearm 1106 includes anchoring tangs or projections as shown in theimplants 840 and 850 of FIGS. 12 and 13, and the end termination member1086 is removed (e.g., cut off) from the arm 1106. The sheath may thenbe removed from the patient, by pulling the proximal end of the sheath,leaving the arm 1106 of the implant 1082 in place. This may allow forimplantation of a tanged mesh implant, or an implant with tanged mesharms, such as the arms of the implant 840 of FIG. 12, or an implant witharms having lateral projections, such as implant 850 of FIG. 13, withoutunnecessary irritation of patient tissue such as may be caused byadvancing a rough edge across patient tissue. The tangs or projectionsmay act as a soft tissue anchor, to anchor the arm in patient tissue.

FIG. 24 shows an exemplary implant 1150 positioned in the pelvic floortissue of a patient. The implant 1150 includes a center portion 1152,posterior arms 1154 and 1156, and anterior arms 1158, 1160, 1162, and1164. The anterior arms 1158 and 1162 are inserted into the rightobturator foramen 1170 a, while the anterior arms 1160 and 1164 areinserted into the left obturator formation 1170 b. The posterior arms1154 and 1156 are inserted into the right 1172 a and left 1172 bsacrospinous ligaments, respectively. In the illustrative example, thearms 1154, 1156, 1158, 1160, 1162, and 1164 include tangs that anchorthe implant 1150 in the patient's tissue.

In certain implementations, the operator generally delivers the implant1082 along a path that avoids certain pelvic structures, such as theinternal pudendal artery, the pudendal canal, the perineal nerve, thelabial nerve, and other vascular and nerve structures.

In one embodiment, any of the arms of the implant may be delivered usinga single incision procedure. For example, the anterior arms may bedelivered via a transvaginal procedure, in which the arms are extendedtoward target locations in the obturator foramen and anchored in placewith a soft tissue anchor. The posterior arms may be deliveredtransvaginally to target locations in the sacrospinous ligament andanchored in place with a soft tissue anchor.

According to an alternative embodiment, the end termination 1090 and theassociated arm 1110 is inserted into a target region of the levator animuscle, such as into the tendinous arch of the levator ani muscle. Thisprocedure is described in greater detail with respect to theabove-mentioned reference “Systems, Devices and Methods for TreatingPelvic Floor Disorder” (U.S. application Ser. No. 11/400,111).

According to various embodiments, different sheathes and/or shafts maybe used to insert different arms of an implant. For example, the sixarms of implant 1082 of FIG. 23 may each be inserted using a differentmethod and/or a different sheath and/or delivery device. According toone embodiment, a separate delivery device and a separate sheath areused for each arm of an implant.

Exemplary mesh materials that may be used for the slings and, asapplicable, any of the support legs include, for example, syntheticmaterials, natural materials (e.g., biological) or a combinationthereof. The mesh may be fabricated from any of a number ofbiocompatible materials, such as nylon, silicone, polyethylene,polyester, polyethylene, polyurethane, polypropylene, fluoropolymers,copolymers thereof, combinations thereof, or other suitable syntheticmaterial(s). The material may be, for example, a biodegradable syntheticmaterial. The term “biodegradable,” as used herein, refers to theproperty of a material that dissolves in the body. Such materials mayalso be absorbed into the body, i.e., bioabsorbable.

Suitable bioabsorbable synthetic materials include, without limitation,polylactic acid (PLA), polyglycolic acid (PGA), poly-L-Iactic acid(PLLA), poly(amino acids), polypeptides, human dermis and decellularizedanimal tissue. Human tissues may be derived, for example, from humancadaveric or engineered human tissue. Animal tissues may be derived, forexample, from porcine, ovine, bovine, and equine tissue sources. Thematerial may be an omnidirectional material, a material that hasequivalent tensile strength from any direction, such as pericardium ordermis. Alternatively, the material may be an oriented material, havinga single direction where the tensile strength of the material is thehighest. Oriented materials may include rectus fascia and/or facia lata.In addition to those listed above, exemplary biodegradable polymerswhich may be used to form the slings or, as applicable, the armsdisclosed herein, include, without limitation, polylactic acid,polyglycolic acid and copolymers and mixtures thereof, such aspoly(Llactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolic acid[polyglycolide (PGA)], poly(L-lactide-co-D,L-lactide) (PLLNPLA),poly(L-lactide-co-glycolide) (PLLAlPGA), poly(D,L-lactide-co-glycolide)(PLNPGA), poly(glycolide-co-trimethylene carbonate) (PGNPTMC),poly(D,L-lactide-co-caprolactone) (PLAlPCL), andpoly(glycolide-cocaprolactone) (PGNPCL); polyethylene oxide (PEO);polydioxanone (PDS); polypropylene fumarate; polydepsipeptides,poly(ethyl glutamate-eo-glutamic acid),poly(tert-butyloxy-carbonylmethyl glutamate); polycaprolactone (PCL),poly(hydroxyl butyrate), polycaprolactone co-butyl acrylate,polyhydroxybutyrate (PHBT) and copolymers of poly hydroxy butyrate;polyphosphazenes, poly(phosphate ester); maleic anhydride copolymers,polyiminocarbonates, poly[(97.5% dimethyl-trimethylenecarbonate)-co-(2.5% trimethylene carbonate)], cyanoacrylate,hydroxypropylmethylcellulose; polysaccharides, such as hyaluronic acid,chitosan and regenerate cellulose; poly(amino acid) and proteins, suchas poly(lysine), Poly(glutamic acid), gelatin and collagen; and mixturesand copolymers thereof.

The sling assemblies, including the various slings and, as applicable,the arms disclosed herein, may include an agent for release into thepatient's tissues. One illustrative agent is a tissue growth factorthat, when applied to the patient's tissues in a pharmaceuticallyacceptable amount, promotes well-organized collagenous tissue growth,such as scar tissue growth, preferably, in large quantities. Accordingto one feature, the agent mayor may not block or delay thedissolvability of the biodegradable materials. Whether or not an agentblocks or delays such dissolvability may be controlled by selectingdiffering methods for loading the agent onto the sling. Exemplary tissuegrowth factors may include natural and/or recombinant proteins forstimulating a tissue response to enhance collagenous tissue growth.Exemplary growth factors that may be used include, but are not limitedto, platelet-derived growth factor (PDGF), fibroblast growth factor(FGF), transforming growth factor-beta (TGF-beta), vascular endotheliumgrowth factor (VEGF), ActivinlTGF and sex steroid, bone marrow growthfactor, growth hormone, Insulin-like growth factor 1, and combinationsthereof. The agent may also include a hormone, including but not limitedto estrogen, steroid hormones, and other hormones to promote growth ofappropriate collagenous tissue such as scar tissue. The agent may alsoinclude stem cells or other suitable cells derived from the hostpatient. These cells may be fibroblast, myoblast, or other progenitorcells to mature into appropriate tissues.

In various illustrative embodiments, the agent may include one or moretherapeutic agents. The therapeutic agents may be, for example,anti-inflammatory agents, including steroidal and non-steroidalanti-inflammatory agents, analgesic agents, including narcotic andnon-narcotic analgesics, local anesthetic agents, antispasmodic agents,growth factors, gene-based therapeutic agents, and combinations thereof.

Exemplary steroidal anti-inflammatory therapeutic agents(glucocorticoids) include, but are not limited to,21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumehtasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol priopionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methyolprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylaminoacetate, prednisone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortal, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, and pharmaceutically acceptable salts thereof.

Exemplary non-steroidal anti-inflammatory therapeutic agents include,but are not limited to, aminoarylcarboxylic acid derivatives such asenfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamicacid, mefanamic acid, niflumic acid, talniflumate, terofenamate andtolfenamic acid; aryl acetic acid derivatives such as acemetacin,alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium,etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac,glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac,metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide,tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon,butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac,ketorolac and tinoridine; arylpropionic acid derivatives such asalminoprofen, benoxaprofen, bucloxic acid; carprofen, fenoprofen,flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen,ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen,pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid;pyrazoles such as difenamizole and epirizole; pyrazolones such asapazone, benzpiperylon, feprazone, mofebutazone, morazone,oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone,ramifenazone, suxibuzone and thiazolinobutazone; salicylic acidderivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal, etersalate, fendosal,gentisic acid, glycol salicylate, imidazole salicylate, lysineacetylsalicylate, mesal amine, morpholine salicylate, 1-naphthylsalicylate, olsalazine, parsalmide, phenyl acetylsalicylate, phenylsalicylate, sal acetamide, salicylamine o-acetic acid, salicylsulfuricacid, salsalate and sulfasalazine; thiazinecarboxamides such asdroxicam, isoxicam, piroxicam and tenoxicam; others such as

-acetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyricacid, amixetrine, bendazac, benzydamine, bucolome, difenpiramide,ditazol, emorfazone, guaiazulene, nabumetone, nimesulide, orgotein,oxaceprol, paranyline, perisoxal, pifoxime, proquazone, proxazole andtenidap; and pharmaceutically acceptable salts thereof.

Exemplary narcotic analgesic therapeutic agents include, but are notlimited to, alfentanil, allylprodine, alphaprodine, anileridine,benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene,codeine, codeine methyl bromide, codeine phosphate, codeine sulfate,desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine,dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol,dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone,eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine,etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine,isomethadone, ketobemidone, levorphanol, lofentanil, meperidine,meptazinol, metazocine, methadone hydrochloride, metopon, morphine,myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol,normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone,papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine,piminodine, piritramide, proheptazine, promedol, properidine, propiram,propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceuticallyacceptable salts thereof.

Exemplary non-narcotic analgesic agents that may be combined with theslings of the invention include, but are not limited to, aceclofenac,acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid,alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate),aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine,ammonium salicylate, amtolmetin guacil, antipyrine, antipyrinesalicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen,benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide,5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin,calcium acetylsalicylate, carbamazepine, carbiphene, carsalam,chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen,ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol,difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate,dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole,etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone,flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazolesalicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin,ketoprofen, ketorolac, p-Iactophenetide, lefetamine, loxoprofen, lysineacetylsalicylate, magnesium acetylsalicylate, methotrimeprazine,metofoline, miroprofen, morazone, morpho line salicylate, naproxen,nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide,perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll,phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol,pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone,proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate,salacetamide, salicin, salicylamide, salicylamide o-acetic acid,salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate,sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate,tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol,xenbucin, zomepirac, and pharmaceutically acceptable salts thereof.

Exemplary local anesthetic therapeutic agents include, but are notlimited to, ambucaine, amolanone, amylocaine hydrochloride, benoxinate,benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben,butanilicaine, butethamine, butoxycaine, carticaine, chloroprocainehydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucainehydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride,dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin,fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxy tetracaine,isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine,mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine,naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacainehydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine,prilocaine, procaine, propanocaine, proparacaine, propipocaine,propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine,salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine,zolamine, and phannaceutically acceptable salts thereof.

Exemplary antispasmodic therapeutic agents include, but are not limitedto, alibendol, ambucetamide, aminopromazine, apoatropine, bevoniummethyl sulfate, bietamiverine, butaverine, butropium bromide,n-butylscopolammonium bromide, caroverine, cimetropium bromide,cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride,cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate,diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine,fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentoniumbromide, tlavoxate, flopropione, gluconic acid, guaiactamine,hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine,nafiverine, octamylamine, octaverine, oxybutynin chloride,pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaveriumbromide, piperilate, pipoxolan hydrochloride, pramiverin, prifiniumbromide, properidine, prop ivane, propyromazine, prozapine, racefemine,rociverine, spasmolytol, stilonium iodide, sultroponium, tiemoniumiodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,trifolium, trimebutine, n,n-Itrimethyl-3,3-diphenyl-propylamine,tropenzile, trospium chloride, xenytropium bromide, and phannaceuticallyacceptable salts thereof.

According to another feature, the slings disclosed herein may includeany suitable end portions, such as tissue dilators, anchors, andassociation mechanisms for associating the sling with a delivery device.Without limitation, examples of slings, sling assemblies, sling deliverydevices and approaches, sling assembly-to-delivery device associationmechanisms, and sling anchoring mechanisms including features with whichthe slings and sling assemblies of the invention may be employed aredisclosed in U.S. Pat. No. 6,042,534, entitled “Stabilization sling foruse in minimally invasive pelvic surgery,” U.S. Pat. No. 6,755,781,entitled “Medical slings,” U.S. Pat. No. 6,666,817, entitled “Expandablesurgical implants and methods of using them,” U.S. Pat. No. 6,042,592,entitled “Thin soft tissue surgical support mesh,” U.S. Pat. No.6,375,662, entitled “Thin soft tissue surgical support mesh,” U.S. Pat.No. 6,669,706, entitled “Thin soft tissue surgical support mesh,” U.S.Pat. No. 6,752,814, entitled “Devices for minimally invasive pelvicsurgery,” U.S. Ser. No. 10/918,123, entitled “Surgical Slings,” U.S.patent application Ser. No. 10/641,376, entitled “Spacer for slingdelivery system,” U.S. patent application Ser. No. 10/641,192, entitled“Medical slings,” U.S. Ser. No. 10/641,170, entitled “Medical slings,”U.S. Ser. No. 10/640,838, entitled “Medical implant,” U.S. patentapplication Ser. No. 10/460,112, entitled “Medical slings,” U.S. patentapplication Ser. No. 10/631,364, entitled “Bioabsorbable casing forsurgical sling assembly,” U.S. Ser. No. 10/092,872, entitled “Medicalslings,” U.S. patent application Ser. No. 10/939,191, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/774,842, entitled “Devices for minimally invasive pelvic surgery,”U.S. patent application Ser. No. 10/774,826, entitled “Devices forminimally invasive pelvic surgery,” U.S. Ser. No. 10/015,114, entitled“Devices for minimally invasive pelvic surgery,” U.S. patent applicationSer. No. 10/973,010, entitled “Systems and methods for sling deliveryand placement,” U.S. patent application Ser. No. 10/957,926, entitled“Systems and methods for delivering a medical implant to an anatomicallocation in a patient,” U.S. patent application Ser. No. 10/939,191,entitled “Devices for minimally invasive pelvic surgery,” U.S. patentapplication Ser. No. 10/918,123, entitled “Surgical slings,” U.S. patentapplication Ser. No. 10/832,653, entitled “Systems and methods for slingdelivery and placement,” U.S. patent application Ser. No. 10/642,397,entitled “Systems, methods and devices relating to delivery of medicalimplants,” U.S. patent application Ser. No. 10/642,395, entitled“Systems, methods and devices relating to delivery of medical implants,”U.S. patent application Ser. No. 10/642,365, entitled “Systems, methodsand devices relating to delivery of medical implants,” U.S. patentapplication Ser. No. 10/641,487, entitled “Systems, methods and devicesrelating to delivery of medical implants,” U.S. patent application Ser.No. 10/094,352, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/093,498, entitled “Systemfor implanting an implant and method thereof,” U.S. patent applicationSer. No. 10/093,450, entitled “System for implanting an implant andmethod thereof,” U.S. patent application Ser. No. 10/093,424, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/093,398, entitled “System for implanting animplant and method thereof,” and U.S. patent application Ser. No.10/093,371, entitled “System for implanting an implant and methodthereof.” Moreover, the slings disclosed herein may be adapted for usein pelvic floor repair systems and related devices and methods. Suchsystems include, for example, those disclosed in U.S. Pat. No.6,197,036, entitled “Pelvic Floor Reconstruction,” U.S. Pat. No.6,691,711, entitled “Method of Correction of Urinary and GynecologicalPathologies Including Treatment of Incontinence,” U.S. Pat. No.6,884,212, entitled “Implantable Article and Method,” U.S. Pat. No.6,911,003, entitled “Transobturator Surgical Articles and Methods,” U.S.patent application Ser. No. 10/840,646, entitled “Method and Apparatusfor Cystocele Repair,” U.S. application Ser. No. 10/834,943, entitled“Method and Apparatus for Treating Pelvic Organ Prolapse,” U.S. patentapplication Ser. No. 10/804,718, entitled “Prolapse Repair,” and U.S.patent application Ser. No. 11/115,655, entitled “Surgical Implants andRelated Methods,” U.S. patent application Ser. No. 11/400,111, entitled“Systems, Devices, and Methods for Treating Pelvic Floor Disorders,” andU.S. patent application Ser. No. 11/399,913, entitled “Systems, Devices,and Methods for Sub-Urethral Support,” the entire contents of all ofwhich are incorporated herein by reference.

The foregoing embodiments are merely examples of various configurationsof the materials described and disclosed herein. Additionalconfigurations can be readily deduced from the foregoing, includingcombinations thereof, and such configurations and continuations areincluded within the scope of the invention. The specifications and otherdisclosures in the patents, patent applications, and other referencescited herein are hereby incorporated by reference in their entirety.

What is claimed is:
 1. A system for delivering an implant to a patient,comprising: an implant having an attachment strap, the attachment straphaving an end portion, the end portion defining projections on at leastone lateral edge of the attachment strap, the projections adapted toanchor the implant in soft tissue of the patient's pelvic floor; an endtermination member attached to the attachment strap, the end terminationmember defining a lumen; a shaft having a first portion having a firstsize and a second portion having a second size larger than the firstsize, the shaft defining a shoulder between the first portion and thesecond portion, the shaft being configured to be received within thelumen of the end termination member such that at least a portion of thefirst portion of the shaft is disposed within the lumen of the endtermination member; and a sheath having a first end and a second end,the sheath defining a hollow center extending from the first end to thesecond end, the sheath configured to receive the shaft such that theshaft extends through the hollow center from the first end to the secondend.
 2. The system of claim 1, further comprising a handle coupled tothe shaft.
 3. The system of claim 1, further comprising a handle coupledto the sheath.
 4. The system of claim 1, wherein the end terminationmember includes a loop.
 5. The system of claim 1, wherein the endtermination member includes a ring.
 6. The system of claim 1, whereinthe end termination member has two radially extending legs.
 7. Thesystem of claim 1, wherein at least one of the shaft and the sheath aresubstantially straight.
 8. The system of claim 1, wherein at least oneof the shaft and the sheath have a curved shape.
 9. The system of claim1, wherein the shaft is rigid and the sheath is flexible.
 10. The systemof claim 1, wherein the sheath is curved and the shaft is flexiblematerial, and the shaft bends to extend through the hollow center of thesheath upon insertion.
 11. The system of claim 1, wherein the shaft islonger than the sheath.
 12. The system of claim 1, further comprising atip attached to a distal end of the sheath.
 13. The system of claim 1,wherein the implant has at least two arms and a posterior extensionportion that is adapted to be positioned under a posterior pelvicregion.
 14. The system of claim 13, wherein the two arms arch toward theposterior pelvic region.
 15. The system of claim 1, wherein the implanthas four arms and is adapted to be positioned under an anterior pelvicregion.
 16. The system of claim 15, wherein the four arms extendlaterally from a central portion of the implant and in an anteriordirection, toward the anterior pelvic region.